Physiological Signals, Activity and Posture for Surface Mounted Insertable Cardiac Monitor in Heart Failure Study (HAPI-HF)

Boston Scientific

Status

Completed

Conditions

Heart Failure, Diastolic

Heart Failure, Systolic

Treatments

Device: Wearable cardiac monitor

Study type

Observational

Funder types

Industry

Identifiers

NCT04112576

C2116

Details and patient eligibility

About

To characterize the physiological signals collected from a Wearable Cardiac Monitor (WCM) prototype device in subjects with heart failure and preserved ejection fraction (HFpEF) and compare against signals from subjects with heart failure and reduced ejection fraction (HFrEF).

To evaluate the relationship of physiological signals measured from a wearable cardiac monitor (WCM) prototype device with ECHO measures of systolic and diastolic function

Full description

This is a non-randomized, feasibility study that will enroll up to 100 participants clinically diagnosed with HFpEF or HFrEF. Approximately 70% of participants will have HFpEF and 30% will have HFrEF.

There will be one study visit per participant. The study visit includes device placement and data collection during postural changes. Echocardiograms will also be collected throughout the study and at least 30% of participants will undergo a submaximal exercise test. The device will then be removed.

Enrollment

100 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with NYHA class II or III heart failure defined by symptoms and signs of heart failure
Documented episode of decompensated heart failure in the past 3 years, which either: a) resulted in a hospital admission (primary diagnosis) or b) was treated in out-patient clinic
HFrEF defined by documented evidence of EF ≤ 40% OR
HFpEF defined by documented evidence of:
EF ≥ 50% and no prior record of EF < 40%
Evidence of relevant structural heart disease or diastolic dysfunction on echocardiographic as defined in the 2016 ESC guidelines
Able to understand and willing to provide written informed consent to participate in the trial
Age 21 years old or greater
Willing and able to participate in the required testing

Exclusion criteria

Prior hospitalization, CV event or surgery within 6 weeks
Subject is currently enrolled in another clinical trial (excluding registries) that may interfere with the placement of the study system or include the usage of investigational drugs.
Patients with Active Implantable Medical Devices
Known allergy to materials used in the study (adhesive tape, titanium, ECG electrodes)
Have a prosthetic cardiac valve, previously underwent cardiac valve surgery or have hemodynamically unstable (as judged by local investigator) valvular disease
Subject is pregnant as indicated by patient record
Patients with rash or open wound on torso locations where investigational devices will be placed
Patient deemed as clinically unstable or unsuitable to perform prescribed testing as judged by the local investigator